Food and Drug Regulations (C.R.C., c. 870)

C.04.070. B.C.G. vaccine shall be prepared from living B.C.G. organisms that

• (a) have been obtained directly from a source approved by the Director;

• (b) are proved to be non-pathogenic by an acceptable method; and

• (c) have a history of successful use in the production of B.C.G. vaccine.

C.04.071. No fabricator shall employ any person in the manufacture of B.C.G. vaccine unless such person

• (a) has been and remains free from all forms of tuberculous infection,

• (b) undergoes every six months a medical examination, that shall include an X-ray examination of the chest, for the presence of tuberculosis, such examination being made by a qualified, practising physician who shall sign a certificate of such person’s freedom from tuberculosis, and such certificate shall be kept on file and be available at all times, and

• (c) resides in a household that is at all times free from active tuberculosis,

nor shall a fabricator employ such person in any other laboratory position.

C.04.072. The preparation, preservation and packaging/labelling of B.C.G. vaccine shall be conducted under the direct supervision of an experienced bacteriologist who has

• (a) not less than three years postgraduate training in bacteriology and immunology;

• (b) specialized in the field of bacteriology; and

• (c) at least one year of practical experience in the manufacture of B.C.G. vaccine.

C.04.073. No fabricator shall permit any culture that is not a B.C.G. culture to be at any time on any premises that are used for the manufacture of B.C.G. vaccine.

C.04.074. A packager/labeller shall test by an acceptable method, after filling of the final container, each lot of B.C.G. vaccine for the presence of contaminating micro-organisms and when so tested it shall be free therefrom.

C.04.075. Notwithstanding section C.04.074, a fluid B.C.G. vaccine may be released for sale if no growth has appeared upon the test culture medium after an incubation of 24 hours, but if there is evidence of the presence of contaminating micro-organisms in any lot during the test period of 10 days the packager/labeller shall at once recall such lot.

C.04.076. Every fabricator and packager/labeller shall determine the number of viable B.C.G. organisms in each lot of vaccine by an acceptable method and shall keep a record of the number.